The Amo Ophthalmic Surgical System
FDA 510(k) K060366 · Advanced Medical Optics, Inc.
510(k) numberK060366
Submission
- Device name
- The Amo Ophthalmic Surgical System
- Applicant
- Advanced Medical Optics, Inc.
Santa Ana, CA, US - Received
- February 13, 2006
- Decision date
- April 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was The Amo Ophthalmic Surgical System cleared by the FDA?
The Amo Ophthalmic Surgical System (K060366) received a 510(k) decision of Substantially Equivalent on April 7, 2006, 53 days after the submission was received.
What is the product code of K060366?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.